Clinical Operations Lead (Tokyo or Osaka)

PSI CRO·Tokyo, Tokyo, Japan

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About the role

Hybrid Clinical Operations Lead role based at either the Tokyo or Osaka office. Responsibilities include mentoring and supervising Monitors, conducting and overseeing clinical monitoring visits, supporting staff development and appraisal, managing site-level quality and investigational product accountability, supervising Site Management Associates, and supporting resource allocation. Requires a Life Sciences degree or equivalent education, training and experience, at least two years of CRA mentoring or training experience, full working proficiency in Japanese and English, MS Office proficiency, and travel availability up to 60%.

Key requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience.
• At least 2 years of relevant experience
• Required skills: CRA mentoring or training, Mentoring and training Clinical Operations staff, Clinical site selection, initiation, monitoring and closeout visits, Monitoring visit planning and conduct, Clinical site relationship management, Monitor performance appraisal support, Clinical Operations team coaching, Supervision of Site Management Associates, Quality control and data integrity compliance, Investigational Product and clinical study supply accountability and reconciliation, Resource allocation and staff utilization, MS Office applications, Planning and working in a dynamic team environment, Communication, Collaboration, Problem-solving, Availability to travel up to 60%
• Required languages: Japanese, English

Opportunity details

• Workplace: Hybrid
• Posted: Jul 2, 2026

Employer’s role description

Job title: Clinical Operations Lead (Tokyo or Osaka)

Location: Tokyo, Tokyo, Japan

Employment type: Full-time

Workplace type: Hybrid

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

In this role, you will build focus on line management and mentoring of Monitors on project-specific activities.

Hybrid workstyle at either Tokyo or Osaka office.

The scope of responsibilities will include:

Prepare, conduct and report site selection, initiation, routine monitoring and closeout visits.
Act as a Mentor for the Monitors on project-specific activities and supporting their professional development.
Plan and conduct supervised monitoring visits with training, authorization, and ongoing assessment purposes.
Build and maintain good relationships with sites’ staff involved in the study conduct.
Contribute to the performance appraisal of monitors.
Training, coaching and mentoring the Clinical Operations team.
Supervise activities of Site Management Associates related to the flow of documents and laboratory supplies between the site and the Central/Regional Laboratory/Central Reviewer.
Development and implementation of quality control, ensuring data integrity and compliance at a site level.
Ensure proper handling, accountability and reconciliation of all Investigational Products and clinical study supplies.
Supports Clinical Operations Managers with resource allocation and

utilization of departmental staff

Performs additional Clinical Operations supervisory tasks at the discretion of

their Line Manager

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience.

Minimum 2 years of CRA mentoring or training experience.
Full working proficiency in Japanese and English.
Ability to successfully mentor and train Clinical Operations staff.
Proficiency in MS Office applications.
Availability to travel (up to 60%).
Ability to plan and work in a dynamic team environment.
Communication, collaboration, and problem-solving skills.

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.